A trend towards an OS benefit for osimertinib over SoC was observed (HR = 0.63, 95% CI: 0.45–0.88; p = 0.0068); however, the p-value did not reach what was required (p <0.0015) for statistical significance at the current maturity. (Figure 3)

Figure 1. PFS by investigator assessment

Figure 2. PFS* in patients by CNS metastases at study entry

Figure 3. Overall survival interim analysis

Safety

The median duration of exposure was 16.2 months for osimertinib (range: 0.1–27.4) and 11.5 months (range: 0–26.2) for SoC.